Patient Self-Reported Adherence to Ritonavir-Boosted Darunavir Combined With Either Raltegravir or Tenofovir Disoproxil Fumarate/Emtricitabine in the NEAT001/ANRS143 Trial
Background: The NEAT001/ANRS143 trial demonstrated noninferiority of ritonavir-boosted darunavir combined with either ral-tegravir (RAL + DRV/r) or tenofovir disoproxil fumarate/ emtricitabine (TDF/FTC + DRV/r) in HIV-positive, antiretroviralnaive adults. In post hoc analyses, however, RAL + DRV/r s...
| Autores: | , , , , , , , , , , , , |
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| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2018 |
| País: | España |
| Institución: | Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau) |
| Repositorio: | r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau |
| OAI Identifier: | oai:iibsantpau.fundanetsuite.com:p3708 |
| Acceso en línea: | https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=3708 https://europepmc.org/articles/pmc6250251 |
| Access Level: | acceso abierto |
| Palabra clave: | adherence HIV antiretrovirals NtRTI-sparing regimen raltegravir darunavir/ritonavir |
| Sumario: | Background: The NEAT001/ANRS143 trial demonstrated noninferiority of ritonavir-boosted darunavir combined with either ral-tegravir (RAL + DRV/r) or tenofovir disoproxil fumarate/ emtricitabine (TDF/FTC + DRV/r) in HIV-positive, antiretroviralnaive adults. In post hoc analyses, however, RAL + DRV/r showed inferiority in patients with baseline CD4+,200/mm(3) and HIV-1 RNA $ 100,000 copies per milliliter. This preplanned ancillary study was conducted to assess whether differences in adherence might explain efficacy results. Setting: Phase III, open-label, randomized, multicenter study in 15 European countries (ClinicalTrials. gov, NCT01066962). Methods: Seven hundred seventy-four participants self-reported adherence (modified AIDS Clinical Trials Group questionnaire) over 96 weeks [383 RAL + DRV/r (twice daily; 5 pills/day), 391 TDF/FTC + DRV/r (once daily; 4 pills/day)]. Primary endpoint was $ 95% versus,95% adherence to prescribed doses recorded (1) over the last 4 days or (2) on the visual analogue scale over the last 30 days. Results: Characteristics, except age, were similar between arms; 9% had CD4+,200 cells/mm(3) and HIV-1 RNA $ 100,000 copies per milliliter. Adherence $ 95% in the last 4 days (P = 0.029) or at the visual analogue scale (P = 0.0072) was higher with TDF/FTC + DRV/r than with RAL + DRV/r. Adherence $ 95% over the last 4 days was associated with lower probability of virological failure (P = 0.015). Adherence in patients with baseline CD4+,200 cells/mm(3) and HIV-1 RNA $ 100,000 copies per milliliter was similar to the rest of the population, and not significantly associated with efficacy measures, with no significant differences between arms. Conclusion: Adherence was high and slightly better in the TDF/ FTC + DRV/r than in the RAL + DRV/r arm. No convincing evidence was found that higher failure rate in the RAL + DRV/r arm in the subgroup with worse baseline viroimmunological status is caused by adherence differences. |
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